nucleic acid amplification
FDA Grants Marketing Authorization for Cue Health COVID-19 At-Home Molecular Test
The nucleic acid amplification test is the first at-home, over-the-counter test for COVID-19 to be granted marketing authorization using the traditional premarket review pathway.
Lucira Health Receives Health Canada Authorization for At-Home COVID-19, Flu Test
The nucleic acid amplification test for COVID-19 and influenza A/B delivers results in 30 minutes from a shallow nasal swab.
Lucira Health Nabs CE Mark for COVID-19, COVID/Flu Molecular Tests
The company plans to make its combination COVID-19 and influenza test available in the EU in the third quarter of 2022.
The molecular diagnostic firm has also begun international commercialization of its products in Canada and Singapore.
Sense Biodetection, Cruinn Diagnostics Ink Distribution Deal for COVID-19 Test in Ireland
The single-use molecular test, which received CE marking last week, requires no instrument and returns results in 15 minutes.
Nov 10, 2021
Cue Health Revenues up Massively in Q3
Jan 31, 2020
NeuMoDx T. Vaginalis, M. Genitalium Assay CE Marked
Oct 2, 2019
Geneoscopy Raises $6.9M in Series A Financing
Aug 2, 2018
FDA Clears Hologic Panther Fusion GBS Assay
Sep 11, 2017